The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Shofu Resin Glaze.
| Device ID | K163568 |
| 510k Number | K163568 |
| Device Name: | SHOFU RESIN GLAZE |
| Classification | Coating, Filling Material, Resin |
| Applicant | Shofu Dental Corporation 1225 Stone Drive San Marcos, CA 92078 |
| Contact | Mauro Malzyner |
| Correspondent | Mauro Malzyner Shofu Dental Corporation 1225 Stone Drive San Marcos, CA 92078 |
| Product Code | EBD |
| CFR Regulation Number | 872.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-19 |
| Decision Date | 2017-08-16 |